MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number UNKNOWN

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2021

Event Type  malfunction  

Event Description

Event 3 of 7: an angiodynamics senior distribution manager reported an issue discovered during a retrospect observation of perm-catheter reinsertion, between june to december 2021.It was reported that 7 out of 50 cases resulted in the removal and replacement of bioflo duramax dialysis catheters due to leakage from the connection between the tip cap and the transparent tube and/or destruction of the hub.The patients did not experience any adverse effects or harm as a result of these issues but did require removal and replacement of the devices.

Manufacturer Narrative

It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).For each of the 7 events, reference: event 1: (b)(4) 1317056-2022-00025; event 2: (b)(4) 1317056-2022-00026; event 3: (b)(4); event 4: (b)(4) 1317056-2022-00028; event 5: (b)(4) 1317056-2022-00029; event 6: (b)(4) 1317056-2022-00030; event 7: (b)(4) 1317056-2022-00031.

Manufacturer Narrative

As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of extension tubing leaked at hub luer cannot be confirmed, no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A potential root cause for this type of failure is over torquing of the hub to extension tubing junction during cleaning/use of the device.A dhr review wasunable to be conducted since there was no reported lot number or upn.A ship history report (shr) for the customer shows they purchase multiple bioflo dialysis catheter upns.A dhr review of the shr lots is not warranted.Labeling review: the following is provided as a reference from dfu item for this product: warnings.In the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism and remove catheter.Use of excessive pull force on the catheter may cause the suture wing to detach from the bifurcate.Do not use acetone on any part of the catheter tubing.Exposure to this agent may cause catheter damage.Do not use sharp instruments near the extension tubing or catheter lumen.Do not use scissors to remove dressing.Catheter will be damaged if clamps other than what is provided with this kit are used.Clamping of the tubing repeatedly in the same location may weaken tubing.Avoid clamping near the luers and hub of the catheter.Examine catheter lumen and extensions before and after each treatment for damage.Repeated over tightening of bloodlines, syringes, and caps will reduce connector life and could lead to potential connector failure.If luer lock connectors are cleansed with a cleansing solution, allow the solution to dry fully before applying catheter end caps.Tape end caps between treatments to safeguard them against accidental removal.Note: endexo technology is intended to reduce catheter-related thrombus, and is not intended to treat or eliminate existing thrombus.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).For each of the 7 events, reference: event 1: (b)(6) 1317056-2022-00025; event 2: (b)(6) 1317056-2022-00026; event 3: (b)(6) 1317056-2022-00027; event 4: (b)(6) 1317056-2022-00028; event 5: (b)(6) 1317056-2022-00029; event 6: (b)(6) 1317056-2022-00030; event 7: (b)(6) 1317056-2022-00031.

• Brand Name: BIOFLO DIALYSIS CATHETER
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 13424989
• MDR Text Key: 288616653
• Report Number: 1317056-2022-00027
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K131260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1